Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - Validation Study

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT04248842
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

Brief Summary

For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 27/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. As part of the WARD-COPD project, this validation study aim to assess the accuracy of physiologic parameters derived from standard and wireless patient monitors

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-22
• Study Start: 2020-01-23
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Status Verified: 2020-06
• Primary Completion: 2020-06-04
• Study Completion: 2020-06-04
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients admitted with AECOPD

Exclusion Criteria

• Patient expected not to cooperate
• Patient allergic to plaster, plastic or silicone
• Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of pulse rate (beats per minute) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)	Two hours of monitoring (measurement interval of 15 mins)	Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of peripheral oxygen saturation (percent) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)	Two hours of monitoring (measurement interval of 15 mins)	Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of heart rate (beats per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue)	Two hours of monitoring (measurement interval of 15 mins)	Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of respiratory rate (breaths per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue) vs direct observation	Two hours of monitoring (measurement interval of 15 mins)	Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the three methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of systolic and diastolic blood pressure (mmHg) measurement with Meditech BP-05 vs standard monitoring (Phillips IntelliVue)	Two hours of monitoring (measurement interval of 15 mins)	Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark